Cleared Traditional

K894940 - DATASCOPE STEERING HANDLE

K894940 is the FDA 510(k) clearance for DATASCOPE STEERING HANDLE by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K894940 · Datascope Corp. · Cardiovascular device
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Nov 1989
Decision
90d
Days
Class 2
Risk

K894940 is an FDA 510(k) clearance for the DATASCOPE STEERING HANDLE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on November 1, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Datascope Corp. devices

Submission Details

510(k) Number K894940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date November 01, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 454
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K894940.
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · Advanced Cardiovascular Systems, Inc. · Jun 1990
CRAGG CONVERTIBLE WIRE
K897152 · Boston Scientific Corp · Feb 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · Advanced Cardiovascular Systems, Inc. · Feb 1990
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · Cordis Corp. · Oct 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · Datascope Corp. · Oct 1989
USCI PROBE LINX EXTENSION WIRE
K890404 · C.R. Bard, Inc. · Aug 1989